Solid TumorPhase 1/2NCT03195478

A Study of Nivolumab in Combination With Ipilimumab in Chinese Participants With Previously Treated Advanced or Recurrent Solid Tumors

A Phase 1/2 study testing Nivolumab and Ipilimumab in people with Solid Tumor, run by Bristol-Myers Squibb at 12 sites in China.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

The purpose of this study is to evaluate the safety and effectiveness of Nivolumab in combination with Ipilimumab in Chinese participants with previously treated late stage cancer. Read more about this study

Who is it for?: Ages 18 years and older
Conditions the study is for: Solid Tumor
What is being tested?: Nivolumab and Ipilimumab
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 37 participants
Where: 12 sitesChina
Study dates: 2 Aug 2017to 5 Jan 2024
Phase: Phase 1/2
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 years and older
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

Mainland Chinese participants with advanced or recurrent solid tumors
Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
One prior anti-cancer therapy that did not work or documented refusal to receive chemotherapy or biological therapy

Who cannot join

Cancer that has spread to the brain or central nervous system unless it has been adequately treated . In addition, either no longer receiving corticosteroids, or on a stable or decreasing dose of no more than 10 mg daily prednisone (or equivalent)
Active, known or suspected autoimmune disease or infection
Positive blood screen for chronic infection of hepatitis B or hepatitis C (HCV antibody positive unless HCV RNA is negative)
Prior immuno-oncology therapy
Other protocol-defined inclusion/exclusion criteria apply

Trial locations and contacts

12 sites in 1 country.

City, postcode or hospital

12 sites in 1 country

China12 sites

Local Institution - 0015
Beijing, Beijing Municipality, 100021
Local Institution - 0001
Beijing, Beijing Municipality, 100142
Local Institution - 0018
Chengdu, Sichuan, 610041
Local Institution
Guangzhou, Guangdong, 510080
Local Institution - 0012
Guangzhou, Guangdong, 510655
Local Institution - 0013
Hangzhou, Zhejiang, 310009
Local Institution - 0011
Harbin, Heilongjiang, 155040
Local Institution - 0016
Shanghai, Shanghai Municipality, 200025
Local Institution - 0004
Tianjin, Tianjin Municipality, 300222
Local Institution - 0021
Wuhan, Hubei, 430030
Local Institution - 0020
Xi'an, Shan1xi, 710061
Local Institution
Zhengzhou, Henan, 450052

Other trials in China

About this study

Official title: A Phase 1/2 Study of Nivolumab (BMS-936558) in Combination With Ipilimumab (BMS-734016) in Chinese Participants With Previously Treated Metastatic or Recurrent Solid Tumors

The purpose of this study is to evaluate the safety and effectiveness of Nivolumab in combination with Ipilimumab in Chinese participants with previously treated late stage cancer.

Conditions: Solid Tumor
Being tested: Nivolumab, Ipilimumab

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

NivolumabDrug
Also called BMS-936558, Opdivo
Specified dose on specified days
IpilimumabDrug
Also called BMS-734016, Yervoy
Specified dose on specified days

Study groups in NCT03195478
Study group	Role	What they receive
Nivo/Ipi Combination Therapy A	Experimental	Not described Receives: Drug: Nivolumab; Drug: Ipilimumab
Nivo/Ipi Combination Therapy B	Experimental	Not described Receives: Drug: Nivolumab; Drug: Ipilimumab
Nivo/Ipi Combination Therapy C	Experimental	Not described Receives: Drug: Nivolumab; Drug: Ipilimumab
Nivo/Ipi Combination Arm D	Experimental	Not described Receives: Drug: Nivolumab; Drug: Ipilimumab

What is being measured

The primary outcome is the main question the study is designed to answer.

Number of Participants With Adverse Events (AEs) in Part 1.
Number of participants with Adverse events
Measured: From first dose to 100 days post last dose (Approximately on average Arm A: 8.77 Months, Arm B 20.4 Months, Arm C 24.1 Months)
Number of Participants With Serious Adverse Events (SAEs) in Part 1.
Number of participants with Adverse events
Measured: From first dose to 100 days post last dose (Approximately on average Arm A: 8.77 Months, Arm B 20.4 Months, Arm C 24.1 Months)
Number of Participants With Adverse Events Leading to Discontinuation in Part 1.
Number of participants with Adverse events
Measured: From first dose to 100 days post last dose (Approximately on average Arm A: 8.77 Months, Arm B 20.4 Months, Arm C 24.1 Months)
Number of Participants With Adverse Events Leading to Death in Part 1.
Number of participants with Adverse Events leading to death.
Measured: From first dose to 100 days post last dose (Approximately on average Arm A: 8.77 Months, Arm B 20.4 Months, Arm C 24.1 Months)
Number of Participants With Clinical Laboratory Abnormalities in Part 1.
Number of participants with clinical laboratory abnormalities.
Measured: From first dose to 100 days post last dose (Approximately on average Arm A: 8.77 Months, Arm B 20.4 Months, Arm C 24.1 Months)
BICR-Assessed ORR in Part 2
ORR is defined as the number of subjects with a best overall response (BOR) of confirmed complete response (CR) or partial response (PR) assessed by BICR, according to RECIST v1.1 criteria, divided by the number of treated subjects.
The BOR is defined as the best response designation recorded between the date of first dose and the date of initial objectively documented progression per RECIST v1.1 or the date of subsequent therapy, whichever occurs first. For participants without documented progression or subsequent therapy, all available response designations will contribute to the BOR determination. For purposes of analysis, if a subject receives one dose and discontinues the study without assessment or receives subsequent therapy prior to assessment, this participant will be counted in the denominator (as nonrespondent).
Measured: between the date of first dose and the date of initial objectively documented progression per RECIST v1.1 or the date of subsequent therapy, whichever occurs first as assessed by BICR. (Approximately on average 3.21 Months)

Secondary outcomes (19)

Cmax - Maximum Observed Serum Concentration in Part 1.
Cmax - Maximum observed serum concentration in Part 1.
Measured: At Cycle 1 Day 1 and Cycle 3 Day 1 for Arm A, Cycle 1 and Cycle 2 Day 1 for Arm B and C (1 cycle = 42 days)
Tmax - Time of Maximum Observed Serum Concentration in Part 1.
Tmax - Time of maximum observed serum concentration in Part 1.
Measured: At Cycle 1 Day 1 and Cycle 3 Day 1 for Arm A, Cycle 1 and Cycle 2 Day 1 for Arm B and C (1 cycle = 42 days)
AUC(0-T) - Area Under the Plasma Concentration-time Curve in Part 1.
AUC(0-T) - Area under the plasma concentration-time curve from time zero to the last time of the last quantifiable concentration. in Part 1.
Measured: At Cycle 1 Day 1 and Cycle 3 Day 1 for Arm A, Cycle 1 and Cycle 2 Day 1 for Arm B and C (1 cycle = 42 days)
AUC(TAU) - Area Under the Concentration-time Curve in One Dosing Interval in Part 1.
AUC(TAU) - Area under the concentration-time curve in one dosing interval in Part 1.
Measured: At Cycle 1 Day 1 and Cycle 3 Day 1 for Arm A, Cycle 1 and Cycle 2 Day 1 for Arm B and C (1 cycle = 42 days)
Ceoinf - Serum Concentration Achieved at the End of Study Drug Infusion in Part 1.
Ceoinf - Serum concentration achieved at the end of study drug infusion in Part 1.
Measured: At Cycle 1 Day 1 and Cycle 3 Day 1 for Arm A, Cycle 1 and Cycle 2 Day 1 for Arm B and C (1 cycle = 42 days)
Ctau - Concentration at the End of Dosing Interval in Part 1.
Ctau - Concentration at the end of dosing interval in Part 1. The Ctau is equivilant to the CTrough at these time points.
Measured: At Cycle 1 Day 1 and Cycle 3 Day 1 for Arm A, Cycle 1 and Cycle 2 Day 1 for Arm B and C (1 cycle = 42 days)
CLT - Total Body Clearance in Part 1.
CLT - Total body clearance in Part 1.
Measured: At Cycle 3 Day 1 for Arm A, Cycle 2 Day 1 for Arm B and C (1 cycle = 42 days)
Css-avg - Average Concentration Over a Dosing Interval (AUC(TAU)/Tau) in Part 1.
Css-avg - Average concentration over a dosing interval (AUC(TAU)/tau) in Part 1.
Measured: At Cycle 1 Day 1 and Cycle 3 Day 1 for Arm A, Cycle 1 and Cycle 2 Day 1 for Arm B and C (1 cycle = 42 days)
AI - Accumulation Index in Part 1.
AI - Accumulation index; ratio of an exposure measure at steady-state to that after the first dose (exposure measure includes AUC (TAU) in Part 1.
Here SS = Steady State Here FD = First Dose
Measured: At Cycle 3 Day 1 for Arm A, Cycle 2 Day 1 for Arm B and C (1 cycle = 42 days)
T-HALFeff - Effective Elimination Half-life in Part 1.
T-HALFeff - Effective elimination half-life that explains the degree of accumulation observed for a specific exposure measure (exposure measure includes AUC(TAU), Cmax, or Ctau) in Part 1.
Measured: At Cycle 3 Day 1 for Arm A, Cycle 2 Day 1 for Arm B and C (1 cycle = 42 days)
Number of Participants With Nivolumab Anti Drug Antibodies in Part 1.
Number of participants with nivolumab Anti Drug Antibodies in Part 1.
Measured: At baseline and from first dose to last dose (Approximately on average of Arm A 24.54 weeks, Arm B 76 weeks, Arm C 92.5 Weeks)
Number of Participants With Ipilimumab Anti Drug Antibodies in Part 1.
Number of participants with Ipilimumab Anti Drug Antibodies in Part 1.
Measured: At baseline and from first dose to last dose (Approximately on average of Arm A 24.54 weeks, Arm B 76 weeks, Arm C 92.5 Weeks)
Investigator-Assessed ORR in Part 2
ORR is defined as the number of subjects with a best overall response (BOR) of confirmed complete response (CR) or partial response (PR) assessed by Investigator, according to RECIST v1.1 criteria, divided by the number of treated subjects.
The BOR is defined as the best response designation recorded between the date of first dose and the date of initial objectively documented progression per RECIST v1.1 or the date of subsequent therapy, whichever occurs first. For participants without documented progression or subsequent therapy, all available response designations will contribute to the BOR determination. For purposes of analysis, if a subject receives one dose and discontinues the study without assessment or receives subsequent therapy prior to assessment, this participant will be counted in the denominator (as nonrespondent).
Measured: between the date of first dose and the date of initial objectively documented progression per RECIST v1.1 or the date of subsequent therapy, whichever occurs first as assessed by the Investigator. (Approximately on average 2 Months)
Investigator-Assessed Disease Control Rate (DCR) in Part 2
The percentage of participants whose BOR is confirmed CR or confirmed PR or stable disease (SD) for at least 12 weeks as per investigator.
Measured: between the date of first dose and the date of initial objectively documented progression per RECIST v1.1 as assessed by the Investigator. (Approximately on average 5 Months)
BICR-Assessed Disease Control Rate (DCR) in Part 2
The percentage of participants whose BOR is confirmed CR or confirmed PR or stable disease (SD) for at least 12 weeks as per BICR.
Measured: Approximately 5.92 Months
BICR-Assessed Duration of Response (DOR) in Part 2
The time between the date of first confirmed response to the date of the first documented tumor progression (per RECIST 1.1), or death due to any cause, whichever occurs first as per BICR.
Measured: From first dose to 100 days post last dose (approximately 102 weeks)
Investigator-Assessed Duration of Response (DOR) in Part 2
The time between the date of first confirmed response to the date of the first documented tumor progression (per RECIST 1.1), or death due to any cause, whichever occurs first as per investigator.
Measured: From first dose to 100 days post last dose (approximately 102 weeks)
BICR-Assessed Progression Free Survival (PFS) in Part 2
The time between the date of first confirmed response to the date of the first documented tumor progression (per RECIST 1.1), or death due to any cause, whichever occurs first as per BICR.
Measured: From first dose to 100 days post last dose (approximately 102 weeks)
Investigator-Assessed Progression Free Survival (PFS) in Part 2
The time between the date of first confirmed response to the date of the first documented tumor progression (per RECIST 1.1), or death due to any cause, whichever occurs first as per investigator.
Measured: From first dose to 100 days post last dose (approximately 102 weeks)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

2 Aug 20175 Jan 2024

First posted22 Jun 2017
Study start2 Aug 2017
Primary completion5 Jan 2024
Study completion5 Jan 2024

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Other trials for Solid TumorStudies of the same condition, open and under way.
More trials run by Bristol-Myers SquibbThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 1/2
Primary purpose: Treatment
Allocation: Non-randomised
Intervention model: Sequential
Masking: None (open label)
Enrolment: 37 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT03195478
Sponsor's protocol ID: CA209-672
Status last verified: Aug 2025
First submitted: 20 Jun 2017
Last updated: 15 Sep 2025
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No
FDA-regulated drug: Yes
FDA-regulated device: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

RecruitingPhase 1/2
Study of INBRX-106 and INBRX-106 in Combination With Pembrolizumab (Keytruda®) in Subjects With Locally Advanced or Metastatic Solid Tumors (Hexavalent OX40 Agonist)
Solid Tumor, Non-Small Cell Lung Cancer
Active, not recruitingPhase 1
A Study to Assess Safety, Tolerability, and Pharmacokinetics of ABSK043 in Patients With Advanced Solid Tumor
Neoplasms
Active, not recruitingPhase 3
A Safety and Efficacy Extension Study of Pertuzumab in Patients With Solid Tumors Previously Enrolled in a Hoffmann-La Roche-Sponsored Pertuzumab Clinical Trial
Solid Tumors
RecruitingPhase 1
IL-12 Genetically Engineered Myeloid Cells in Participants With Relapsed, Refractory Solid Tumors
Relapsed Solid Tumor Malignancies, Refractory Solid Tumor Malignancies
RecruitingObservational study
Immune Checkpoint Inhibitor Toxicity Risk Prediction in Solid Tumors
Malignant Solid Neoplasm

All Solid Tumor trials

Study at a glance

From the registry record, last updated by the sponsor on 15 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Phase 1/2 Study of Nivolumab (BMS-936558) in Combination With Ipilimumab (BMS-734016) in Chinese Participants With Previously Treated Metastatic or Recurrent Solid Tumors
ClinicalTrials.gov ID: NCT03195478
Acronym / sponsor ID: CA209-672
Conditions: Solid Tumor
Phase: Phase 1/2
Study type: Interventional
Recruitment status: Completed
Enrolment: 37 participants (actual)
Lead sponsor: Bristol-Myers SquibbIndustry (pharma, biotech, devices)
Study start: 2 Aug 2017 (actual)
Primary completion: 5 Jan 2024 (actual)
Study completion: 5 Jan 2024 (actual)
First posted: 22 Jun 2017 (actual)
Results: Posted 15 Sep 2025

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

The purpose of this study is to evaluate the safety and effectiveness of Nivolumab in combination with Ipilimumab in Chinese participants with previously treated late stage cancer.

Study design

Primary purpose: Treatment
Allocation: Non-randomised
Intervention model: Sequential
Masking: None (open label)
Number of arms: 4

Arm	Type	Receives
Nivo/Ipi Combination Therapy A	Experimental	Drug: Nivolumab, Drug: Ipilimumab
Nivo/Ipi Combination Therapy B	Experimental	Drug: Nivolumab, Drug: Ipilimumab
Nivo/Ipi Combination Therapy C	Experimental	Drug: Nivolumab, Drug: Ipilimumab
Nivo/Ipi Combination Arm D	Experimental	Drug: Nivolumab, Drug: Ipilimumab

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (3 listed)

Mainland Chinese participants with advanced or recurrent solid tumors
Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
One prior anti-cancer therapy that did not work or documented refusal to receive chemotherapy or biological therapy

Key exclusion criteria (5 listed)

Cancer that has spread to the brain or central nervous system unless it has been adequately treated . In addition, either no longer receiving corticosteroids, or on a stable or decreasing dose of no more than 10 mg daily prednisone (or equivalent)
Active, known or suspected autoimmune disease or infection
Positive blood screen for chronic infection of hepatitis B or hepatitis C (HCV antibody positive unless HCV RNA is negative)
Prior immuno-oncology therapy
Other protocol-defined inclusion/exclusion criteria apply

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
NivolumabAlso: BMS-936558, OpdivoSpecified dose on specified days	Drug	Nivo/Ipi Combination Arm D, Nivo/Ipi Combination Therapy A, Nivo/Ipi Combination Therapy B, Nivo/Ipi Combination Therapy C
IpilimumabAlso: BMS-734016, YervoySpecified dose on specified days	Drug	Nivo/Ipi Combination Arm D, Nivo/Ipi Combination Therapy A, Nivo/Ipi Combination Therapy B, Nivo/Ipi Combination Therapy C

Primary outcome

Number of Participants With Adverse Events (AEs) in Part 1.
Time frame: From first dose to 100 days post last dose (Approximately on average Arm A: 8.77 Months, Arm B 20.4 Months, Arm C 24.1 Months)
Number of participants with Adverse events
Number of Participants With Serious Adverse Events (SAEs) in Part 1.
Time frame: From first dose to 100 days post last dose (Approximately on average Arm A: 8.77 Months, Arm B 20.4 Months, Arm C 24.1 Months)
Number of participants with Adverse events
Number of Participants With Adverse Events Leading to Discontinuation in Part 1.
Time frame: From first dose to 100 days post last dose (Approximately on average Arm A: 8.77 Months, Arm B 20.4 Months, Arm C 24.1 Months)
Number of participants with Adverse events
Number of Participants With Adverse Events Leading to Death in Part 1.
Time frame: From first dose to 100 days post last dose (Approximately on average Arm A: 8.77 Months, Arm B 20.4 Months, Arm C 24.1 Months)
Number of participants with Adverse Events leading to death.
Number of Participants With Clinical Laboratory Abnormalities in Part 1.
Time frame: From first dose to 100 days post last dose (Approximately on average Arm A: 8.77 Months, Arm B 20.4 Months, Arm C 24.1 Months)
Number of participants with clinical laboratory abnormalities.
BICR-Assessed ORR in Part 2
Time frame: between the date of first dose and the date of initial objectively documented progression per RECIST v1.1 or the date of subsequent therapy, whichever occurs first as assessed by BICR. (Approximately on average 3.21 Months)
ORR is defined as the number of subjects with a best overall response (BOR) of confirmed complete response (CR) or partial response (PR) assessed by BICR, according to RECIST v1.1 criteria, divided by the number of treated subjects. The BOR is defined as the best response designation recorded between the date of first dose and the date of initial objectively documented progression per RECIST v1.1 or the date of subsequent therapy, whichever occurs first. For participants without documented progression or subsequent therapy, all available response designations will contribute to the BOR determination. For purposes of analysis, if a subject receives one dose and discontinues the study without assessment or receives subsequent therapy prior to assessment, this participant will be counted in the denominator (as nonrespondent).

19 secondary outcomes

Cmax - Maximum Observed Serum Concentration in Part 1.
Time frame: At Cycle 1 Day 1 and Cycle 3 Day 1 for Arm A, Cycle 1 and Cycle 2 Day 1 for Arm B and C (1 cycle = 42 days)
Tmax - Time of Maximum Observed Serum Concentration in Part 1.
Time frame: At Cycle 1 Day 1 and Cycle 3 Day 1 for Arm A, Cycle 1 and Cycle 2 Day 1 for Arm B and C (1 cycle = 42 days)
AUC(0-T) - Area Under the Plasma Concentration-time Curve in Part 1.
Time frame: At Cycle 1 Day 1 and Cycle 3 Day 1 for Arm A, Cycle 1 and Cycle 2 Day 1 for Arm B and C (1 cycle = 42 days)
AUC(TAU) - Area Under the Concentration-time Curve in One Dosing Interval in Part 1.
Time frame: At Cycle 1 Day 1 and Cycle 3 Day 1 for Arm A, Cycle 1 and Cycle 2 Day 1 for Arm B and C (1 cycle = 42 days)
Ceoinf - Serum Concentration Achieved at the End of Study Drug Infusion in Part 1.
Time frame: At Cycle 1 Day 1 and Cycle 3 Day 1 for Arm A, Cycle 1 and Cycle 2 Day 1 for Arm B and C (1 cycle = 42 days)
Ctau - Concentration at the End of Dosing Interval in Part 1.
Time frame: At Cycle 1 Day 1 and Cycle 3 Day 1 for Arm A, Cycle 1 and Cycle 2 Day 1 for Arm B and C (1 cycle = 42 days)
CLT - Total Body Clearance in Part 1.
Time frame: At Cycle 3 Day 1 for Arm A, Cycle 2 Day 1 for Arm B and C (1 cycle = 42 days)
Css-avg - Average Concentration Over a Dosing Interval (AUC(TAU)/Tau) in Part 1.
Time frame: At Cycle 1 Day 1 and Cycle 3 Day 1 for Arm A, Cycle 1 and Cycle 2 Day 1 for Arm B and C (1 cycle = 42 days)
AI - Accumulation Index in Part 1.
Time frame: At Cycle 3 Day 1 for Arm A, Cycle 2 Day 1 for Arm B and C (1 cycle = 42 days)
T-HALFeff - Effective Elimination Half-life in Part 1.
Time frame: At Cycle 3 Day 1 for Arm A, Cycle 2 Day 1 for Arm B and C (1 cycle = 42 days)
Number of Participants With Nivolumab Anti Drug Antibodies in Part 1.
Time frame: At baseline and from first dose to last dose (Approximately on average of Arm A 24.54 weeks, Arm B 76 weeks, Arm C 92.5 Weeks)
Number of Participants With Ipilimumab Anti Drug Antibodies in Part 1.
Time frame: At baseline and from first dose to last dose (Approximately on average of Arm A 24.54 weeks, Arm B 76 weeks, Arm C 92.5 Weeks)
Investigator-Assessed ORR in Part 2
Time frame: between the date of first dose and the date of initial objectively documented progression per RECIST v1.1 or the date of subsequent therapy, whichever occurs first as assessed by the Investigator. (Approximately on average 2 Months)
Investigator-Assessed Disease Control Rate (DCR) in Part 2
Time frame: between the date of first dose and the date of initial objectively documented progression per RECIST v1.1 as assessed by the Investigator. (Approximately on average 5 Months)
BICR-Assessed Disease Control Rate (DCR) in Part 2
Time frame: Approximately 5.92 Months
BICR-Assessed Duration of Response (DOR) in Part 2
Time frame: From first dose to 100 days post last dose (approximately 102 weeks)
Investigator-Assessed Duration of Response (DOR) in Part 2
Time frame: From first dose to 100 days post last dose (approximately 102 weeks)
BICR-Assessed Progression Free Survival (PFS) in Part 2
Time frame: From first dose to 100 days post last dose (approximately 102 weeks)
Investigator-Assessed Progression Free Survival (PFS) in Part 2
Time frame: From first dose to 100 days post last dose (approximately 102 weeks)

Results and safety

Results posted to the registry on 15 Sep 2025, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Part 1: Arm A	9	1
Part 1: Arm B	9	4
Part 1: Arm C	9	1
Part 2: Arm D	9	7

Primary outcome: Number of Participants With Adverse Events (AEs) in Part 1.

Time frame: From first dose to 100 days post last dose (Approximately on average Arm A: 8.77 Months, Arm B 20.4 Months, Arm C 24.1 Months). Count of participants. Unit: Participants

Measure	Part 1: Arm A n = 9	Part 1: Arm B n = 9	Part 1: Arm C n = 9
Value	7	9	9

Population analysed: All treated participants in Part 1

Primary outcome: Number of Participants With Serious Adverse Events (SAEs) in Part 1.

Time frame: From first dose to 100 days post last dose (Approximately on average Arm A: 8.77 Months, Arm B 20.4 Months, Arm C 24.1 Months). Count of participants. Unit: Participants

Measure	Part 1: Arm A n = 9	Part 1: Arm B n = 9	Part 1: Arm C n = 9
Value	4	3	3

Population analysed: All treated participants in Part 1

Primary outcome: Number of Participants With Adverse Events Leading to Discontinuation in Part 1.

Time frame: From first dose to 100 days post last dose (Approximately on average Arm A: 8.77 Months, Arm B 20.4 Months, Arm C 24.1 Months). Count of participants. Unit: Participants

Measure	Part 1: Arm A n = 9	Part 1: Arm B n = 9	Part 1: Arm C n = 9
Value	3	0	0

Population analysed: All treated participants in Part 1

Primary outcome: Number of Participants With Adverse Events Leading to Death in Part 1.

Time frame: From first dose to 100 days post last dose (Approximately on average Arm A: 8.77 Months, Arm B 20.4 Months, Arm C 24.1 Months). Count of participants. Unit: Participants

Measure	Part 1: Arm A n = 9	Part 1: Arm B n = 9	Part 1: Arm C n = 9
Value	1	1	0

Population analysed: All treated participants in Part 1

19 secondary outcomes are reported in the full results.

Adverse events

Time frame: All-Cause mortality, Adverse Events and Serious Adverse Events: From first dose to 100 days post last dose (Approximately on average Arm A: 8.77 Months, Arm B 20.4 Months, Arm C 24.1 Months and Arm D: 23.8 Months.. Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Part 1: Arm A	4 of 9 (44.4%)	7 of 9 (77.8%)	2 of 9
Part 1: Arm B	3 of 9 (33.3%)	9 of 9 (100%)	2 of 9
Part 1: Arm C	3 of 9 (33.3%)	9 of 9 (100%)	1 of 9
Part 2: Arm D	4 of 9 (44.4%)	9 of 9 (100%)	1 of 9

Limitations and caveats (from the sponsor): "AUC(TAU) for ipi in Arm A, Cycle 1 and Cycle 3 could not be reported because there were not enough PK samples collected. Samples were only taken up to 336 hours after dosing, but the full TAU is 1008 hours, so it was not possible to calculate AUC(TAU) for these cycles. In Cycle 2, only a single PK sample was collected (at Week 3, prior to nivo dose administration) for both nivo and ipi. Therefore, AUC(TAU) could not be calculated or reported for nivo and ipi in Arm A, Cycle 2."

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 15 Sep 2025.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
BMS Clinical Trial InformationLink provided by the sponsor.
BMS Clinical Trial Patient RecruitingLink provided by the sponsor.

Related trials for Solid Tumor

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Bristol-Myers Squibb study director

Bristol-Myers Squibb

12 sites in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 1/2 study testing Nivolumab and Ipilimumab in people with Solid Tumor, run by Bristol-Myers Squibb at 12 sites in China.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 15 Sep 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 12 sites in China. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this combined phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 15 Sep 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Number of Participants With Adverse Events (AEs) in Part 1. (time frame: From first dose to 100 days post last dose (Approximately on average Arm A: 8.77 Months, Arm B 20.4 Months, Arm C 24.1 Months)). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03195478.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Sep 2025.